Fluid Responsiveness in Post-cardiac Surgery

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05957003

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

Condition or Disease	Intervention/Treatment	Phase
Fluid Overload Cardiac Surgery Postoperative Complications	Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test Procedure: Tidal volume challenge test	N/A

Detailed Description

multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.

Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: occlusions test Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO	Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator. The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.
Active Comparator: challenge test Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)	Procedure: Tidal volume challenge test elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Arm

Intervention/Treatment

Active Comparator: occlusions test

Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO

Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test

The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator. The EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.

Active Comparator: challenge test

Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)

Procedure: Tidal volume challenge test

elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds

Outcome Measures

Primary Outcome Measures

The number of volume responder participants could be detected using each fluid responsiveness test [immediate postoperative period]
The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients on mechanical ventilation
Patients ≥18 years of age
patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
patients with normal systolic function of the left and right ventricle
patient is mechanically ventilated with a protective lung strategy

Exclusion Criteria:

Patients with Spontaneously breathing activity
Patients undergoing emergent cardiac surgery.
Patient with severe peripheral arterial occlusive disease
Pregnant women
Contraindication of passive leg raising test
unstable post-operative course
Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;
presence of residual severe tricuspid or any valvular regurgitations
low cardiac output, low ejection fractions (EF ≤45%)
open chest,Pao2/Fio2 ≤ 200

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

tarek abdel hay mostafa, principle investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT05957003

Other Study ID Numbers:

fluid responsiveness

First Posted:

Jul 24, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Jul 24, 2023